12 Weeks Treatment With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Phase IIb, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (5 mg, 10 mg and 25 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo, as Monotherapy, With an Additional Open-label Metformin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00789035
• Other study ID #: 1245.9
• Secondary ID: EudraCT No 2008-
• Status: Completed
• Phase: Phase 2
• First received: October 13, 2008
• Last updated: May 16, 2014
• Start date: October 2008

Study information

• Verified date: May 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: A.N.M.A.T. (National Administration of Medications, Food and Medical Technology)Croatia: Croatian Institute for Medicines Control, HR-10000 ZagrebEstonia: State Agency of Medicines, EE-5041TartuGermany: Federal Institute for Drugs and Medical DevicesItaly: Comitato per la Sperimentazione Clinica dei Medicinali Azienda Ospedaliero-Universitaria PisanaKorea, Republic of: Korea Food and Drug Administration (KFDA)Lithuania: State Medicines Control Agency, LT-01132 VilniusRomania: National Medicines Agency, BucharestRussia: Ministry of Healthcare and Social Development of Russian Federation, MoscowSlovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26Sweden: Medical Products Agency, Box 26, 751 03 Uppsala, Sweden Regional Ethical Review Board of Stockholm, PO Box 289, SE-171 77 Stockholm, Sweden.Taiwan: Department of Health, Executive Yuan, TaiwanUkraine: Ministry of Health Care of Ukraine (MoH of Ukraine)
• Study type: Interventional

Clinical Trial Summary

The objective is to investigate the efficacy, safety and pharmacokinetics of three different doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control. In addition an open-label metformin arm will be assessed

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male and female patients with a diagnosis of type 2 diabetes mellitus

• either treatment-naïve or on a maximum of 1 oral antidiabetic therapy on a stable dose for the10 weeks prior to screening

• HbA1c =6.5 to =9.0% and for treatment-naïve patients:HbA1c >7.0 to =10.0%

• HbA1c >7.0 to =10.0% at Visit 2 (start of run-in) for all patients

• Age between 18 and 80 years

• BMI less than 40 kg/m2

• Signed and dated informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion Criteria:

1. Myocardial infarction, stroke or TIA within 6 months prior to informed consent

2. Impaired hepatic function

3. Renal insufficiency or impaired renal function

4. Disease of central nervous system, or psychiatric disorders or clinically relevant neurologic disorders that may interfere with trial participation

5. Chronic or clinically relevant acute infections

6. Current or chronic urogenital tract infection determined by medical history

7. History of clinically relevant allergy/hypersensitivity

8. Treatment with glitazones, GLP-1 analogues or insulin within 3 months prior to informed consent

9. Treatment with anti obesity drugs

10. Current treatment with systemic steroids

11. Alcohol abuse

12. Treatment with an investigational drug within 2 months prior to informed consent

13. known intolerance to metformin

14. Dehydration

15. Unstable or acute CHF

16. Acute or chronic acidosis

17. Hereditary galactose intolerance

18. Woman of child bearing potential who are nursing or pregnant or not practicing an acceptable method of birth control

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• BI 10773

• placebo

• metformin

Locations

Country	Name	City	State
Argentina	1245.9.54001 Boehringer Ingelheim Investigational Site	Capital Federal
Argentina	1245.9.54002 Boehringer Ingelheim Investigational Site	Capital Federal
Argentina	1245.9.54007 Boehringer Ingelheim Investigational Site	Capital Federal
Argentina	1245.9.54008 Boehringer Ingelheim Investigational Site	Capital Federal
Argentina	1245.9.54009 Boehringer Ingelheim Investigational Site	Capital Federal
Argentina	1245.9.54010 Boehringer Ingelheim Investigational Site	Capital Federal
Argentina	1245.9.54004 Boehringer Ingelheim Investigational Site	Mar del Plata
Argentina	1245.9.54003 Boehringer Ingelheim Investigational Site	Mendoza
Argentina	1245.9.54005 Boehringer Ingelheim Investigational Site	Salta
Argentina	1245.9.54006 Boehringer Ingelheim Investigational Site	Salta
Croatia	1245.9.38504 Boehringer Ingelheim Investigational Site	Karlovac
Croatia	1245.9.38503 Boehringer Ingelheim Investigational Site	Krapinske Toplice
Croatia	1245.9.38506 Boehringer Ingelheim Investigational Site	Osijek
Croatia	1245.9.38505 Boehringer Ingelheim Investigational Site	Varazdin
Croatia	1245.9.38501 Boehringer Ingelheim Investigational Site	Zagreb
Estonia	1245.9.37201 Boehringer Ingelheim Investigational Site	Tallin
Estonia	1245.9.37202 Boehringer Ingelheim Investigational Site	Tallin
Estonia	1245.9.37203 Boehringer Ingelheim Investigational Site	Tallin
Germany	1245.9.49007 Boehringer Ingelheim Investigational Site	Aschaffenburg
Germany	1245.9.49001 Boehringer Ingelheim Investigational Site	Erlangen
Germany	1245.9.49004 Boehringer Ingelheim Investigational Site	Hamburg
Germany	1245.9.49005 Boehringer Ingelheim Investigational Site	Hamburg
Germany	1245.9.49002 Boehringer Ingelheim Investigational Site	Melsungen
Germany	1245.9.49008 Boehringer Ingelheim Investigational Site	Nürnberg
Germany	1245.9.49003 Boehringer Ingelheim Investigational Site	St. Ingbert/Oberwürzbach
Germany	1245.9.49006 Boehringer Ingelheim Investigational Site	Sulzbach-Rosenberg
Italy	1245.9.39006 Boehringer Ingelheim Investigational Site	Genova
Italy	1245.9.39001 Boehringer Ingelheim Investigational Site	Pisa
Italy	1245.9.39003 Boehringer Ingelheim Investigational Site	Pisa
Italy	1245.9.39004 Boehringer Ingelheim Investigational Site	Siena
Italy	1245.9.39005 Boehringer Ingelheim Investigational Site	Treviso
Korea, Republic of	1245.9.82006 Boehringer Ingelheim Investigational Site	Goyang
Korea, Republic of	1245.9.82008 Boehringer Ingelheim Investigational Site	Goyang
Korea, Republic of	1245.9.82007 Boehringer Ingelheim Investigational Site	Incheon
Korea, Republic of	1245.9.82002 Boehringer Ingelheim Investigational Site	Pucheon
Korea, Republic of	1245.9.82001 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1245.9.82004 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1245.9.82005 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1245.9.82009 Boehringer Ingelheim Investigational Site	Suwon
Korea, Republic of	1245.9.82003 Boehringer Ingelheim Investigational Site	Uijeongbu
Lithuania	1245.9.37002 Boehringer Ingelheim Investigational Site	Klaipeda
Lithuania	1245.9.37001 Boehringer Ingelheim Investigational Site	Vilnius
Romania	1245.9.40003 Boehringer Ingelheim Investigational Site	Brasov
Romania	1245.9.40002 Boehringer Ingelheim Investigational Site	Bucharest
Romania	1245.9.40004 Boehringer Ingelheim Investigational Site	Galati
Romania	1245.9.40005 Boehringer Ingelheim Investigational Site	Targu-Mures
Russian Federation	1245.9.70001 Boehringer Ingelheim Investigational Site	Ekaterinburg
Russian Federation	1245.9.70002 Boehringer Ingelheim Investigational Site	Kazan
Russian Federation	1245.9.70003 Boehringer Ingelheim Investigational Site	Nizhniy Novgorod
Russian Federation	1245.9.70004 Boehringer Ingelheim Investigational Site	Petrozavodsk
Russian Federation	1245.9.70005 Boehringer Ingelheim Investigational Site	Smolensk
Russian Federation	1245.9.70006 Boehringer Ingelheim Investigational Site	Yaroslavl
Russian Federation	1245.9.70007 Boehringer Ingelheim Investigational Site	Yaroslavl
Slovakia	1245.9.62002 Boehringer Ingelheim Investigational Site	Bratislava
Slovakia	1245.9.62003 Boehringer Ingelheim Investigational Site	Lucenec
Slovakia	1245.9.62004 Boehringer Ingelheim Investigational Site	Nove Mesto Nad Vahom
Slovakia	1245.9.62001 Boehringer Ingelheim Investigational Site	Prievidza
Sweden	1245.9.46003 Boehringer Ingelheim Investigational Site	Göteborg
Sweden	1245.9.46004 Boehringer Ingelheim Investigational Site	Härnösand
Sweden	1245.9.46005 Boehringer Ingelheim Investigational Site	Lund
Sweden	1245.9.46001 Boehringer Ingelheim Investigational Site	Stockholm
Sweden	1245.9.46002 Boehringer Ingelheim Investigational Site	Västerås
Taiwan	1245.9.88605 Boehringer Ingelheim Investigational Site	Changhua
Taiwan	1245.9.88607 Boehringer Ingelheim Investigational Site	Kaohsiung
Taiwan	1245.9.88604 Boehringer Ingelheim Investigational Site	Taichung
Taiwan	1245.9.88606 Boehringer Ingelheim Investigational Site	Tainan
Taiwan	1245.9.88601 Boehringer Ingelheim Investigational Site	Taipei
Taiwan	1245.9.88603 Boehringer Ingelheim Investigational Site	Taipei
Taiwan	1245.9.88602 Boehringer Ingelheim Investigational Site	Taoyuan
Ukraine	1245.9.38003 Boehringer Ingelheim Investigational Site	Kharkov
Ukraine	1245.9.38004 Boehringer Ingelheim Investigational Site	Kiev
Ukraine	1245.9.38002 Boehringer Ingelheim Investigational Site	Odessa
Ukraine	1245.9.38001 Boehringer Ingelheim Investigational Site	Vinnytsya
Ukraine	1245.9.38005 Boehringer Ingelheim Investigational Site	Vinnytsya

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Argentina,  Croatia,  Estonia,  Germany,  Italy,  Korea, Republic of,  Lithuania,  Romania,  Russian Federation,  Slovakia,  Sweden,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment	Change of HbA1c from baseline after 12 weeks of treatment.; Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups.	Baseline and 12 weeks	No
Secondary	Change of FPG From Baseline After 12 Weeks of Treatment	Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis.; Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups.	Baseline and 12 weeks	No
Secondary	Change of HbA1c From Baseline Over Time	Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis.	Baseline and weeks 4, 8 and 12	No
Secondary	Proportion of Patients Who Achieve an HbA1c =7.0% After 12 Weeks of Treatment	Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%).	12 weeks	No
Secondary	Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment	Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%).	12 weeks	No
Secondary	Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)	Results for change of FPI from baseline at week 12 based on ANCOVA.	Baseline and 12 weeks	No
Secondary	Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)	HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA.	Baseline and 12 weeks	No
Secondary	Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)	HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5). Results are based on ANCOVA.	Baseline and 12 weeks	No
Secondary	Change of Body Weight After 12 Weeks of Treatment	Results for change of body weight after 12 weeks of treatment based on ANCOVA.	Baseline and 12 weeks	No
Secondary	Trough Concentrations of Empagliflozin in Plasma	Pre-dose (within 30 minutes before dosing) trough concentrations of Empagliflozin in plasma	Days 28, 56 and 84	No

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